Collaboration Combines Merck’s Leadership in
Immuno-Oncology with Moderna’s Pioneering mRNA Vaccine Technology
and Rapid Cycle Time, Small-Batch GMP Manufacturing
Capabilities
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and Moderna Therapeutics today announced a strategic
collaboration and license agreement to develop and commercialize
novel messenger RNA (mRNA)-based personalized cancer vaccines. The
collaboration will combine Merck’s established leadership in
immuno-oncology with Moderna’s pioneering mRNA vaccine technology
and GMP manufacturing capabilities to advance individually tailored
cancer vaccines for patients across a spectrum of cancers.
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Moderna and Merck will develop personalized cancer vaccines that
utilize Moderna’s mRNA vaccine technology to encode a patient’s
specific neoantigens, unique mutations present in that specific
patient’s tumor. When injected into a patient, the vaccine will be
designed to elicit a specific immune response that will recognize
and destroy cancer cells. The companies believe that the mRNA-based
personalized cancer vaccines’ ability to specifically activate an
individual patient’s immune system has the potential to be
synergistic with checkpoint inhibitor therapies, including Merck’s
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). In addition, Moderna
has developed a rapid cycle time, small-batch manufacturing
technique that will uniquely allow the company to supply vaccines
tailored to individual patients within weeks.
Under the terms of the agreement, Merck will make an upfront
cash payment to Moderna of $200 million, which Moderna will use to
lead all research and development efforts through proof of concept.
The development program will entail multiple studies in several
types of cancer and include the evaluation of mRNA-based
personalized cancer vaccines in combination with Merck’s KEYTRUDA®
(pembrolizumab). Moderna will also utilize the upfront payment to
fund a portion of the build-out of a GMP manufacturing facility in
suburban Boston for the purpose of personalized cancer vaccine
manufacturing.
Following human proof of concept studies, Merck has the right to
elect to make an additional undisclosed payment to Moderna. If
exercised, the two companies will then equally share cost and
profits under a worldwide collaboration for the development of
personalized cancer vaccines. Moderna will have the right to elect
to co-promote the personalized cancer vaccines in the U.S. The
agreement entails exclusivity around combinations with KEYTRUDA.
Moderna and Merck will each have the ability to combine mRNA-based
personalized cancer vaccines with other (non-PD-1) agents.
“Combining immunotherapy with vaccine technology may be a new
path toward improving outcomes for patients,” said Dr. Roger
Perlmutter, president, Merck Research Laboratories. “While the area
of personalized cancer vaccine research has faced challenges in the
past, there have been many recent advances, and we believe that
working with Moderna to combine an immuno-oncology approach, using
KEYTRUDA, with mRNA-based personalized cancer vaccines may
have the potential to transform the treatment of cancer.”
“Our team has made significant progress since beginning our work
in personalized cancer vaccines just last year. Through this
collaboration with Merck, we are now well-positioned to accelerate
research and development with a goal of entering the clinic in
2017, as well as to apply our unique GMP manufacturing capabilities
to support the rapid production of these highly individualized
vaccines,” said Stéphane Bancel, chief executive officer of
Moderna. “We value our continued collaboration with Merck, and we
look forward to working together to harness the potential of
personalized cancer vaccines and immuno-oncology to bring a new
treatment paradigm to patients.”
Merck and Moderna have an existing collaboration and license
agreement focused on the discovery and development of mRNA-based
infectious disease vaccines and passive immunity treatments.
Moderna is also advancing its own pipeline of infectious disease
vaccine candidates and currently has two phase 1 studies underway
in Europe and the U.S.
About KEYTRUDA® (pembrolizumab) Injection 100
mg
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.
KEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma.
KEYTRUDA is also indicated for the treatment of patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors express
PD-L1 as determined by an FDA-approved test with disease
progression on or after platinum-containing chemotherapy. Patients
with EGFR or ALK genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving KEYTRUDA. This indication is approved under accelerated
approval based on tumor response rate and durability of response.
An improvement in survival or disease-related symptoms has not yet
been established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous
infusion over 30 minutes every three weeks for the approved
indications.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
Immune-mediated pneumonitis, including fatal cases, occurred in
patients receiving KEYTRUDA® (pembrolizumab). Pneumonitis occurred
in 32 (2.0%) of 1567 patients with melanoma, including Grade 1
(0.8%), 2 (0.8%), and 3 (0.4%) pneumonitis. Pneumonitis occurred in
19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3
(1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis and more frequently in
patients with a history of asthma/chronic obstructive pulmonary
disease (5.4%) or prior thoracic radiation (6.0%). Monitor patients
for signs and symptoms of pneumonitis. Evaluate suspected
pneumonitis with radiographic imaging. Administer corticosteroids
for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2;
permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent
Grade 2 pneumonitis.
Immune-mediated colitis occurred in 31 (2%) of 1567 patients
with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%)
colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550
patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis.
Monitor patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA
(pembrolizumab) for Grade 2 or 3; permanently discontinue KEYTRUDA
for Grade 4 colitis.
Immune-mediated hepatitis occurred in patients receiving
KEYTRUDA. Hepatitis occurred in 16 (1%) of 1567 patients with
melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%)
hepatitis. Monitor patients for changes in liver function.
Administer corticosteroids for Grade 2 or greater hepatitis and,
based on severity of liver enzyme elevations, withhold or
discontinue KEYTRUDA.
Hypophysitis occurred in 13 (0.8%) of 1567 patients with
melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%)
hypophysitis. Hypophysitis occurred in 1 (0.2 %) of 550 patients
with NSCLC, which was Grade 3 in severity. Monitor patients for
signs and symptoms of hypophysitis (including hypopituitarism and
adrenal insufficiency). Administer corticosteroids and hormone
replacement as clinically indicated. Withhold KEYTRUDA for Grade 2;
withhold or discontinue for Grade 3 or 4 hypophysitis.
Hyperthyroidism occurred in 51 (3.3%) of 1567 patients with
melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism.
Hypothyroidism occurred in 127 (8.1%) of 1567 patients with
melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism
occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2
(0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38
(6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3
(0.2%) hypothyroidism. Thyroid disorders can occur at any time
during treatment. Monitor patients for changes in thyroid function
(at the start of treatment, periodically during treatment, and as
indicated based on clinical evaluation) and for clinical signs and
symptoms of thyroid disorders. Administer replacement hormones for
hypothyroidism and manage hyperthyroidism with thionamides and
beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for
Grade 3 or 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis,
occurred in 3 (0.1%) of 2117 patients. Monitor patients for
hyperglycemia or other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA and administer
anti-hyperglycemics in patients with severe hyperglycemia.
Immune-mediated nephritis occurred in patients receiving
KEYTRUDA. Nephritis occurred in 7 (0.4%) of 1567 patients with
melanoma including, Grade 2 (0.2%), 3 (0.2%), and 4 (0.1%)
nephritis. Monitor patients for changes in renal function.
Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA (pembrolizumab) for Grade 2; permanently
discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can
occur. For suspected immune-mediated adverse reactions, ensure
adequate evaluation to confirm etiology or exclude other causes.
Based on the severity of the adverse reaction, withhold KEYTRUDA ®
(pembrolizumab) and administer corticosteroids. Upon improvement to
Grade 1 or less, initiate corticosteroid taper and continue to
taper over at least 1 month. Based on limited data from clinical
studies in patients whose immune-related adverse reactions could
not be controlled with corticosteroid use, administration of other
systemic immunosuppressants can be considered. Resume KEYTRUDA when
the adverse reaction remains at Grade 1 or less following
corticosteroid taper. Permanently discontinue KEYTRUDA for any
Grade 3 immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
The following clinically significant, immune-mediated adverse
reactions occurred in less than 1% (unless otherwise indicated) of
1567 patients with melanoma: arthritis (1.6%), exfoliative
dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. The following clinically significant,
immune-mediated adverse reactions occurred in less than 1% of 550
patients with NSCLC: rash, vasculitis, hemolytic anemia, serum
sickness, and myasthenia gravis.
Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2117 patients. Monitor patients for signs
and symptoms of infusion related reactions including rigors,
chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia,
and fever. For Grade 3 or 4 reactions, stop infusion and
permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA can cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA.
In Trial 6, KEYTRUDA was discontinued due to adverse reactions
in 9% of 555 patients with advanced melanoma; adverse reactions
leading to discontinuation in more than one patient were colitis
(1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%),
polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse
reactions leading to interruption of KEYTRUDA occurred in 21% of
patients; the most common (≥1%) was diarrhea (2.5%). The most
common adverse reactions with KEYTRUDA vs ipilimumab were fatigue
(28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), and
nausea (21% with KEYTRUDA). Corresponding incidence rates are
listed for ipilimumab only for those adverse reactions that
occurred at the same or lower rate than with KEYTRUDA
(pembrolizumab).
In Trial 2, KEYTRUDA was discontinued due to adverse reactions
in 12% of 357 patients with advanced melanoma; the most common
(≥1%) were general physical health deterioration (1%), asthenia
(1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea
(1%), and maculo-papular rash (1%). The most common adverse
reactions with KEYTRUDA vs chemotherapy were fatigue (43% with
KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%), constipation
(22% vs 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs 20%),
and decreased appetite (20% with KEYTRUDA). Corresponding incidence
rates are listed for chemotherapy only for those adverse reactions
that occurred at the same or lower rate than with KEYTRUDA.
KEYTRUDA was discontinued due to adverse reactions in 14% of 550
patients with NSCLC. Serious adverse reactions occurred in 38% of
patients. The most frequent serious adverse reactions reported at
least 2% of patients were pleural effusion, pneumonia, dyspnea,
pulmonary embolism, and pneumonitis. The most common adverse
reactions (reported in at least 20% of patients) were fatigue
(44%), cough (29%), decreased appetite (25%), and dyspnea
(23%).
No formal pharmacokinetic drug interaction studies have been
conducted with KEYTRUDA.
It is not known whether KEYTRUDA is excreted in human milk.
Because many drugs are excreted in human milk, instruct women to
discontinue nursing during treatment with KEYTRUDA and for 4 months
after the final dose.
Safety and effectiveness of KEYTRUDA have not been established
in pediatric patients.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey – from lab to clinic – to potentially
bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 300 clinical
trials evaluating our anti-PD-1 therapy across more than 30 tumor
types. We also continue to strengthen our immuno-oncology portfolio
through strategic acquisitions and are prioritizing the development
of several promising immunotherapeutic candidates with the
potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. Through our prescription medicines,
vaccines, biologic therapies, and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
About Moderna Therapeutics
Moderna is a clinical stage pioneer of messenger RNA
Therapeutics™, an entirely new in vivo drug technology that
produces human proteins, antibodies and entirely novel protein
constructs inside patient cells, which are in turn secreted or
active intracellularly. This breakthrough platform addresses
currently undruggable targets and offers a potentially superior
alternative to existing drug modalities for a wide range of
diseases and conditions. Moderna is developing and plans to
commercialize its innovative mRNA drugs through its own ventures
and its strategic relationships with established pharmaceutical and
biotech companies. Its current ventures are: Onkaido, focused on
oncology, Valera, focused on infectious diseases, Elpidera, focused
on rare diseases, and Caperna, focused on personalized cancer
vaccines. Cambridge-based Moderna is privately held and currently
has strategic agreements with AstraZeneca, Alexion Pharmaceuticals
and Merck. To learn more, visit www.modernatx.com.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2015
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA
(pembrolizumab)
at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and
Patient Information/Medication Guide for KEYTRUDA
at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
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MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo,
908-236-1108orInvestors:Teri Loxam, 908-740-1986orJustin Holko,
908-740-1879orModernaMedia:Liz Melone,
617-256-6622orInvestors:Maren Winnick, 617-674-5297
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